BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLX 2003

    MDR report key: 13276027 · Received January 18, 2022

    Report

    Report Number
    9710055-2022-00014
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Report Date
    January 18, 2022
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLX 2003. THE USE OF A MORE POWERFUL BULB THAN ALLOWED OCCURRED (150W INSTEAD OF 50W) WHICH CAUSED SIMMERING OF DEVICE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THE USE OF A MORE POWERFUL BULB CAN LEAD TO PATIENT BURN OR TO THE SHORT CIRCUIT CAUSING A FIRE OR ELECTRIC SHOCK. BASED ON INFORMATION PROVIDED BY GETINGE TECHNICIAN, THE AFFECTED DEVICE WAS REPAIRED AND COMMISSIONED. IT ALSO PASSED FUNCTIONAL AND RUN TESTS. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION DUE TO EXCESSIVE HEAT OF THE BULB WHICH LEAD TO SIMMERING, WHICH CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION DO NOT INDICATE IF UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS RELATED TO INVESTIGATED ISSUE, REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. PERFORMED INVESTIGATION DID NOT REVEAL ANY TREND OF THE OCCURRENCE OF EXCESSIVE HEAT OF BULBS ON HLX DEVICES. AS STATED BY SUBJECT MATTER EXPERT AT MANUFACTURING SITE, AN EXCESSIVE HEAT OF THE BULB LED TO DETERIORATION OF THE PERIPHERAL COMPONENTS OF THE OPTICAL PART OF THE HLX 2000 LIGHT HEAD. IT WAS IDENTIFIED THAT THE EXCESSIVE HEAT WAS CAUSED BY THE NON-CONFORMITY OF THE HALOGEN BULB. THE WATTAGE OF THE HALOGEN BULB INVOLVED DOES NOT MATCH WITH THE SPECIFICATION: 150W INSTEAD OF 50W. THIS HALOGEN BULB WAS NOT PROVIDED BY GETINGE AND IS NOT AN ORIGINAL SPARE PART, ITS PROVENANCE IS UNKNOWN. TO PREVENT ANY SAFETY ISSUE THE HLX2000 OPERATING INSTRUCTIONS 56351039/E, THE 2022 CONSUMABLES CATALOGUE AND THE HLX2000 SPARE PARTS LIST 56320302 MENTIONS SEVERAL INFORMATION REGARDING THE HALOGEN BULB TO USE. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF D1 BRAND NAME DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D1 BRAND NAME: HLX 2000. CORRECTED D1 BRAND NAME: HLX 2003. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 10TH JANUARY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLX 2000. THE USE OF A MORE POWERFUL BULB THAN ALLOWED OCCURRED (150W INSTEAD OF 50W) WHICH CAUSED SIMMERING OF DEVICE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THE USE OF A MORE POWERFUL BULB CAN LEAD TO PATIENT BURN OR TO THE SHORT CIRCUIT CAUSING A FIRE OR ELECTRIC SHOCK. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 10TH JANUARY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLX 2003. THE USE OF A MORE POWERFUL BULB THAN ALLOWED OCCURRED (150W INSTEAD OF 50W) WHICH CAUSED SIMMERING OF DEVICE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THE USE OF A MORE POWERFUL BULB CAN LEAD TO PATIENT BURN OR TO THE SHORT CIRCUIT CAUSING A FIRE OR ELECTRIC SHOCK. ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON 10TH JANUARY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLX 2000. THE USE OF A MORE POWERFUL BULB THAN ALLOWED OCCURRED (150W INSTEAD OF 50W) WHICH CAUSED SIMMERING OF DEVICE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THE USE OF A MORE POWERFUL BULB CAN LEAD TO PATIENT BURN OR TO THE SHORT CIRCUIT CAUSING A FIRE OR ELECTRIC SHOCK.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    ON 10TH JANUARY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - HLX 2003. THE USE OF A MORE POWERFUL BULB THAN ALLOWED OCCURRED (150W INSTEAD OF 50W) WHICH CAUSED SIMMERING OF DEVICE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THE USE OF A MORE POWERFUL BULB CAN LEAD TO PATIENT BURN OR TO THE SHORT CIRCUIT CAUSING A FIRE OR ELECTRIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948773 HLX 2003 LAMP, SURGICAL FTD MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown